Product Safety Recalls

Product Recall Tracker

Recall D-0364-2025

Description: CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

Recall D-0364-2025 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0364-2025
Event ID96573
DistributionPhysicians and medical facilities in 5 states: AL, CA, FL, GA, ID
Quantity477 bottles.
Recall ReasonDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Drug ClassificationClass II
Drug Code Info20250423
Recall Initiation Date20250131
Report Date20250423
Classification Date20250415
Address94 Worldwide Dr
Dawsonville, GA 30534-6828
United States
Recalling FirmDirect Rx
Initial Notification E-Mail
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